FDA Registration
Active
🇹🇼 Taiwan
OMNIMATE ENTERPRISE CO., LTD.
Reg #: 3009771213
·
FEI: 3009771213
·
Expires 2026
Products
15
Proprietary Names
17
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- OMNIMATE ENTERPRISE CO., LTD.
- Registration Number
- 3009771213
- FEI Number
- 3009771213
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8, Lane 126, Sec. 2, Ligong 1st Rd., Wuchieh Hsiang
- City
- Ilan County Yilan
- Country
- TW
Owner / Operator
- Firm Name
- Omnimate Enterprise Co., LTD.
- Operator Number
- 10041736
- Address
- No.8, Ln. 126, Sec. 2, Ligong 1st Rd., Wujie Township
- City
- Yilan County
- State
- TW-ILA
- Postal Code
- 26841
- Country
- TW
- Correspondent
- Sarah Shan
US Agent
- Business Name
- NEVAP Inc.
- Contact Name
- Benjamin Richard Wang
- Address
- 975 Dionne Way, San Jose
- City
- San Jose
- State
- CA
- ZIP
- 95133
- Country
- US
- [email protected]
- Phone
- 408 3985159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-02-01 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2012-08-27 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2023-12-13 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2016-04-28 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2019-09-10 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2022-08-01 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2012-08-27 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2019-06-06 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2019-06-06 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2012-08-27 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2024-05-13 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2012-08-27 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2019-09-09 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2014-08-20 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2016-04-29 |
Proprietary Names
Single Use Handheld Suction Device
Nasopharyngeal Airway
SnapBlock
Nasal Cannula
GuideBlade
Non-Rebreathing Mask
NeVap ASSET
Laryngeal Mask Airway
Tulip Airway Device
TOAD LIVVE Oral Airway
PROWAY Oropharyngeal Airway
TOAD Big Mouth Oral Airway with Balloon
Sure Spec vaginal speculum
Cushion Face Mask
TOAD Bougie Stylet
Connector, Swivel Connector
Oxygen Supply Tubing
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)